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The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Rosuvastatin + BMS-986322 | Experimental |
| |
| Part 2: Metformin + BMS-986322 + Glucose | Experimental |
| |
| Part 3: Methotrexate + BMS-986322 + Leucovorin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986322 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 21 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 21 days | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 21 days | |
| Apparent terminal phase half-life (T-HALF) | Up to 21 days | |
| Apparent total body clearance (CLT/F) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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| Rosuvastatin | Drug | Specified dose on specified days |
|
| Metformin | Drug | Specified dose on specified days |
|
| Glucose | Dietary Supplement | Specified dose on specified days |
|
| Methotrexate | Drug | Specified dose on specified days |
|
| Leucovorin | Drug | Specified dose on specified days |
|
| Up to 21 days |
| Number of participants with adverse events (AEs) | Up to 51 days |
| Number of participants with vital sign abnormalities | Up to 51 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 51 days |
| Number of participants with physical examination abnormalities | Up to 51 days |
| Number of participants with clinical laboratory abnormalities | Up to 51 days |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D008687 | Metformin |
| D005947 | Glucose |
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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